Efficacy and Safety of Grazax in Children

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Biological: Grazax-R; Biological: Grazax Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00408616

GT-12

Details and patient eligibility

About

The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season

Enrollment: 253 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Boys and girls 5-16 years of age
• A clinical history of grass pollen induced hayfever
• Positive Skin Prick Test to Phleum pratense
• Positive specific IgE against Phleum pratense

Exclusion criteria

• History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
• History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
• History of severe asthma
• Current severe atopic dermatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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253 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Grazax treatment

Treatment:

Biological: Grazax-R

2

Placebo Comparator group

Description:

Grazax Placebo

Treatment:

Biological: Grazax Placebo